Vitruvias Therapeutics is recalling one lot of thyroid medication distributed nationwide after testing found the tablets could be more potent than intended, according to a recall notice published by the U.S. Food and Drug Administration (FDA).
The Auburn, Alabama-based company voluntarily recalled Lot 504950 of Thyroid Tablets, USP 30 mg at the consumer level because of the potential for the medication to be “superpotent.”
The FDA published the company announcement Monday.
Taking superpotent thyroid tablets can cause hyperthyroidism, or an overactive thyroid, with symptoms that can include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate and heart rhythm disturbances, according to the company.
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Elderly patients, pregnant women and infants face greater risks from excessive thyroid hormone levels, particularly with extended use, the company said.
Excess thyroid hormone has been associated with cardiac problems in elderly patients, while overtreatment during pregnancy has been associated with premature delivery and low birth weight. In infants, overtreatment may negatively affect growth and development.
Vitruvias Therapeutics said it has not received any reports of adverse events known to be connected to the recall.
The recalled product carries NDC 69680-166-00 and an expiration date of Sept. 30, 2026. The company released 3,655 units and reported 1,955 units sold.
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The affected lot was distributed nationwide to the company’s direct accounts between Jan. 31, 2025, and Sept. 30, 2025.
Thyroid, USP is derived from porcine thyroid glands and contains levothyroxine and liothyronine. The medication is used to treat hypothyroidism, or an underactive thyroid.
Vitruvias Therapeutics is notifying wholesalers to stop distributing the recalled product and arranging for its destruction.
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Patients currently taking tablets from the affected lot should not stop taking the medication without first contacting their healthcare provider for guidance or a replacement prescription, the company said.
A representative for Vitruvias Therapeutics did not immediately respond to FOX Business’ request for additional information.
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Consumers with questions can contact Vitruvias Therapeutics at safety@vitruvias.com or at 256-239-9373.
Anyone who has experienced problems that may be connected to the medication should contact a physician or healthcare provider.
The recall is being conducted with the knowledge of the FDA.
